MAUDE Adverse Event Report: MOUNTWAY/STREET LIMITED NEPTUNE RECLINING BATH LIFT; LIFE, PATIENT, AC POWERED

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); No Code Available (3191)

Event Type  Injury  

Event Description

Consumer reports that her husband suffered a skin abrasion after the reclining bath seat from neptune cracked and suggests that the products should note that surface can break down and cause injury.The neptune reclining bath lift was purchased from (b)(4) in 2009.This spring, my husband suffered damage to the skin on his bottom due to a ctack in the surface of the bath seat.This problem was reported to neptune, who said that this didn't happen, and to (b)(4), who said it was outside the warranty period.I'm still waiting for a call back from (b)(4) to hear if they'll participate in the purchase of a cover for our replacement seat to protect my husband's skin from this happening again.I think the product literature should include a warning that under certain circumstances the platic surface can break down and pinch or abrade the skin.

• Brand Name: NEPTUNE RECLINING BATH LIFT
• Type of Device: LIFE, PATIENT, AC POWERED
• Manufacturer (Section D): MOUNTWAY/STREET LIMITED
• MDR Report Key: 5018409
• MDR Text Key: 23683471
• Report Number: MW5055559
• Device Sequence Number: 1
• Product Code: FNG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Report Date: 08/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 89 YR
• Patient Weight: 100